In his presentation, Prof. Langer will discuss the approach used by Prestwick Chemical, in order to reduce risks of failing in lead optimization. In more than 10 years of business, the company has been able to deliver seven compounds that proceeded into clinical development, up to phase III.

The positive effects of outsourcing chemical synthesis are enhanced if the provider offers, as the strategic partner, unique expertise and complements the existing internal competencies of pharmaceutical companies. The emerging cooperation model of leased competence offers additional access to high-level specialist knowledge: external service providers are temporarily integrated into internal R&D teams and can support R&D projects flexibly and quickly. Practice examples show that this cooperation model supports the efficient realization of milestones and, in the long-term, helps to build up a high internal competence level, especially in small pharmaceutical companies.

10:00

Targeted Small Molecule Lead Discovery, Optimisation and Development in a Semi-Virtual R&D EnvironmentStephen Shuttleworth, CSO, Karus Therapeutics, United Kingdom

Creating a unique scientific angle; building the right internal team of experimentalists; establishing a network of CROs with the requisite experimental capabilities in preclinical research, and in clinical development; case histories outlining the design of novel therapeutics for treating immune-inflammatory diseases and cancer.

This presentation looks at how we identify the right partner for our outsourcing needs. It also looks into how to create and maintain a mutually beneficial relationship between the parties to ensure a smooth collaboration.

Within Novartis Research, the GDC Preparation Laboratories support medicinal chemistry by providing intermediates, building blocks and other compounds on larger scale. Increased demand for fast scale-up and limited internal capacity have encouraged us to work together with external partners and to outsource some of our projects. The presentation will highlight how we developed a strategy for this outsourcing process and how we evaluated and selected a number of companies which fulfilled our requirements. Some key success determinants, which are used to monitor the outsourcing process, will be discussed. Finally, some case studies will be shown in order to illustrate what we consider a successful outsourcing project.

12:15

Lunch & Networking in Exhibition Hall

13:30

Poster Viewing Session

IP Issues

14:15

U.S. Patent Law of 2011: The Good, The Bad, and The Expensive Thomas Saunders, Of Counsel, Rissman Hendricks & Oliverio, United States of America

In September of 2011, a significantly revised U.S. patent law was enacted. The new law includes the U.S. becoming a “first-to-file” country in 2013. A patent opposition system is also included in the new law. Highlights and costs of this new landscape will be examined along with new strategies.

The presentation will discuss various models of early phase drug discovery outsourcing, highlighting different demographics and factors to consider when selecting a partner. Furthermore, it will underline the importance of relationship management.

While the trend towards externalization of R&D tasks in pharma is unbroken, the cited reasons are many: flexibility, cost base, access to capabilities, and many others. During this session we will discuss key strategic trends and will explore different types of flexibility achieved with different partnership models.

17:30

Drinks Reception

Wednesday, 14 March 2012

New Trends in Outsourcing

09:00

Keynote Presentation

A Global Perspective of Recent Initiatives Across the Value Chain of Drug Discovery and Development Richard Soll, Senior Vice President, WuxiAppTec, United States of America

This presentation will examine the forces and emerging solutions that are shaping the dynamic landscape of drug discovery and development from an outsourcing perspective in addition to emerging efforts of China drug discovery and development.

Medium sized pharma companies have to rely on external sources to complement their internal capabilities. In Almirall we have been outsourcing specific Drug Discovery activities for more than 15 years. Lately we have been moving from the initial tactical approach, based on isolated collaborations, towards a more integrated strategy. We want to obtain more value from our collaborations by increasing the involvement of our partners. Specific approaches to achieve this are: Looking for contribution on the Medicinal Chemistry field, rather that on pure Organic/Synthetic Chemistry. Include chemistry as a part of more global Drug Discovery collaborations involving other disciplines. Sharing the Drug Discovery risk with our partners, by either rewarding the achievement of specific milestones or by sharing the property of the assets generated.

10:00

New Trends in Outsourcing: The Emerging Role of CROs as Virtual Innovation-CentresAlain Vertes, Director, Bio Duro, Switzerland

Large pharmaceutical and biotech companies are increasingly looking outward to gain access to innovation, translating in the rise of CROs as virtual innovation centers. The new innovation trend is exemplified by Beijing-based BioDuro developing unique technology platforms in service business models where all IP rights are retained by client companies.

A new tool to be considered when streamlining pharmaceutical research operations : insourcing. A collaboration model by which, research teams of pharmaceutical companies and supporting CROs, literally work side by side to progress discovery programs.

Drug discovery partnerships form an increasingly important cornerstone of modern drug discovery programmes. Identifying the right partner to facilitate a successful outcome is key. Open innovation-based partnering can be an important component.

14:45

Building an Open Innovation Ecosystem for Drug Discovery and Development Michael Barnes, Co Founder, OI Pharma Partners Ltd, United Kingdom

The concept of Open Innovation (OI) in pharma R&D will be explored, drawing on successful case studies from the Bioscience and IT sectors.

The presentation will discuss both in depth and in detail a series of new outsourcing strategies currently implemented by global drug companies in the emerging markets and the strengths and weakness of the service providers in these countries.